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FDA (Device enforcement)Recalled 2013-06-10closedclass ii

Zimmer, Inc.: Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP

Is my product affected?

Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP

  • UPC 42517600410
  • UPC 42517600510
  • UPC 42517600610
  • UPC 42517600710
  • UPC 42517600810
  • UPC 42517600910

Check against the official notice below — it lists the full affected range.

What happened

Zimmer, Inc. has recalled Persona Knee Trial Articular Surface Provisionals (TASPs) in specific models and lot numbers after receiving complaints of breakage in these components. The recall was retroactive and covered corrective actions the company took earlier in the year. The affected products were distributed worldwide, including across all U.S. states and territories, as well as in Australia, Canada, Germany, India, Japan, Korea, and Singapore, with approximately 70,986 distribution events affected.

The recalled TASPs are identified by six specific item numbers and 48 lot numbers listed in the recall record. The source document does not specify a remedy for consumers who may have received these products.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.

Details from the source

Reason for recall: Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs. Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore. Quantity: 70,986 distribution events Lot/code info: Item Numbers: 42517600410 42517600510 42517600610 42517600710 42517600810 42517600910 Lot Numbers: 62342526 62423918 62423919 62423920 62427414 62482212 62563745 62612225 62656072 62740698 62342527 62405895 62430401 62504179 62511925 62563784 62638665 62695870 62343066 62406967 62432146 62515486 62564324 62691390 62717335 62351291 62374838 62415307 62430397 62518138 62622527 62696875 62357867 62374796 62427836 62441229 62511924 62565948 62563908 62590523 62695295 62361315 62376662 62420192 62434748 62518137 62540059 62563778 62627131 62698733

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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